Phase I Trial of a Recombinant SARS-CoV-2 Vaccine (Sf9 Cell)

Summary

This is a phase I, single-center, randomized, placebo-controlled, double-blind study, to evaluate safety, tolerability and immunogenicity of a recombinant SARS-CoV-2 vaccine (Sf9 cell) in Chinese healthy population aged 18 years and older. After randomization, the trial for each subject will last for approximately 13 months. Screening period is 1 week prior to randomization (Day -7 to Day -1), and each dose of either SARS-CoV-2 vaccine (Sf9 Cell) or placebo will be given intramuscularly (IM) on Day 0 and Day 28 for a two-dose regimen, or on Day 0, Day 14, and Day 28 for a three-dose regimen. Subjects who are ≥18 years old and ≤ 55 years old will be enrolled in adult group, and healthy elderly population who are \>55 years old will be enrolled in elderly group. After adult group completes the follow-up 7 days after first vaccination, elderly group will be recruited.

Conditions

• COVID-19

Interventions

BIOLOGICAL

Two doses of middle-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28

Two doses of middle-dose (20µg/ 0.5ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28.

BIOLOGICAL

Two doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28

Two doses of high-dose (40µg/ 1.0ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28.

BIOLOGICAL

Three doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28

Three doses of high-dose (40µg/ 1.0ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28

BIOLOGICAL

Two doses of placebo at the schedule of day 0, 28（middle-dose group）

Two doses of placebo (0.5ml) at the schedule of day 0, 28

BIOLOGICAL

Two doses of placebo at the schedule of day 0, 28（high-dose group）

Two doses of placebo (1.0ml) at the schedule of day 0, 28

BIOLOGICAL

Three doses of placebo at the schedule of day 0, 14, 28（high-dose group）

Three doses of placebo (1.0ml) at the schedule of day 0, 14, 28

Sponsors & Collaborators

• West China Hospital

  collaborator OTHER

• Jiangsu Province Centers for Disease Control and Prevention

  lead NETWORK

Principal Investigators

• Fengcai Zhu, Doctor · Jiangsu Provincial Center for Disease Control and Prevention

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-08-28

Primary Completion

2020-10-28

Completion

2021-11-23

Countries

• China

Study Locations